JP4253344B2 - Fluid sample analyzer with sealable sample storage reservoir - Google Patents

Abstract

The present invention is directed to devices and methods for determining the presence of analyte in a fluid sample. The devices utilize a sample collection well, an expression plate for expressing sample into the sample collection well, a plunger that drives a lance, and a test compartment containing test elements. The devices also preserve an aliquot of fluid sample in a reservoir for later confirmation testing. When the plunger is lowered into the sample collection well, a lance on the device punctures a frangible material that covers a sample outlet. When the sample outlet is thus opened, fluid sample flows from the sample collection cup to the test compartment. In one embodiment the plunger is lowered as a cap is applied to the device. The devices are useful for detecting the presence of analyte in a wide variety of fluid samples, such as saliva, oral fluids, and more. The invention also provides methods of using the devices, and kits containing the devices.

Description

  The present invention is directed to an apparatus for collecting fluid from a target specimen and analyzing it at high speed.

  The following background of the present invention is intended to facilitate the reader's understanding of the present invention and is not admitted to be prior art.

  The use of banned drugs is a problem that has already been recognized in our society and is becoming an increasingly serious problem. In 2003, the United States Department of Health and Human Services estimated that 8.2 percent of 19.5 million Americans, or 12 years or older, were active banned drug users. The current use of banned drugs means the use of banned drugs during the month preceding the US Department of Health and Human Services survey interview. Marijuana was found to be the most widely used banned drug, with a proportion of 6.2 percent (14.6 million). 2.3 million (1.0 percent) were estimated to be active cocaine users, of which 604,000 were reported using cracks. It is estimated that 1 million people are using hallucinogens and there are 119,000 active users of heroin.

  Drug testing has become a standard procedure in various situations, such as employment, school, sports, and legal procedures, to combat and monitor this problem. To facilitate this effort, the drug testing industry is emerging. The industry offers a variety of drug testing products. A typical product is a urine collection cup that incorporates an analytical test. These devices can be complex and difficult or cumbersome to use, or can cause the unique problem that subjects attempting to hide recent drug abuse can mix the sample. is there. Furthermore, urine samples cannot be collected in certain situations, such as on the roadside or in front of the public.

  Thus, there is a need for better methods and apparatus for performing sample collection and testing.

  The present invention is directed to an apparatus for taking a liquid sample and simultaneously examining the sample for the presence or physical properties of an analyte of interest. In one embodiment, the device is for detecting an analyte of interest in bodily fluids such as oral fluid or saliva. The device has a casing that includes a port for placing a sample collection well. The sample collection well has a sample outlet that provides fluid communication with the upper chamber, squeeze plate, lower chamber, and test compartment. Furthermore, this apparatus is provided with an inspection section for accommodating at least one inspection element. In one embodiment, a seal is located at the lower end of the plunger. When the plunger is moved from the upper position to the lower position, the reservoir placed in fluid communication with the lower chamber of the sample collection well is sealed and the fluid sample is stored for verification. After the plunger is in the lower position, the reservoir is no longer in fluid communication with the reservoir. The device further includes a cap, a portion of the cap interacts with the plunger to push the plunger from the upper position to the lower position. In embodiments where a screw-on cap is used, the plunger is lowered and pushed into the lower position by screwing a cap that partially interacts with the plunger or a component connected to the plunger. The device further includes a plunger having an upper position and a lower position, and a seal. Kits comprising such devices and methods of using such devices are also provided.

  In a first aspect, the present invention provides a test apparatus for detecting an analyte suspected of being present in a fluid sample. The inspection device has a casing with a port for sample collection wells. The apparatus further includes a test compartment that houses at least one test element. The apparatus further includes a sample collection well, which is located in the port and has an upper chamber, a squeeze plate, a lower chamber, and a sample outlet. A sample reservoir is present in the lower chamber or below the lower chamber for storing a fluid sample for verification testing. A plunger is present in the sample collection well and has an upper position and a lower position. The device includes a seal member that is sealably adapted to the sample reservoir when the plunger is in the lower position. In one embodiment, the seal is located at the lower end of the plunger. The device further includes a cap for the sample collection well, and when the cap is attached to the sample collection well, a portion of the cap interacts with the plunger to move the plunger from the upper position to the lower position. Let

  The term “sample reservoir” refers to a sealable area of the device where the fluid sample is stored and protected so that it does not dry or inadvertently become contaminated. The fluid sample can be saved for later verification testing. In one embodiment, the sample reservoir is a depression, which can be located in the lower chamber of the sample collection well (eg, the bottom of the sample collection well). The term “fluid communication” refers to the ability of liquid to flow and the fluid to pass between two regions. Thus, when fluid can flow from the collection well through the sample outlet to the test compartment, the collection well and the test compartment are in fluid communication. The “port” refers to a portion of the casing where the sample collection well is interlocked with the casing, and can be placed in fluid communication with the inspection section. The sample collection well can be inserted into the port as separate parts, or the sample collection well and the casing may be manufactured as a single part. The sample collection well itself can be made from one part, or it can be assembled from child parts. “Sealably fit” means that the sealing member does not enter or escape from the sample reservoir or evaporate from the sample reservoir after the seal is formed. It means that there is no. In one embodiment, the sealing member contacts the floor surface of the lower compartment. In one embodiment, the seal is an O-ring that contacts the floor of the lower chamber around the entire circumference of the reservoir and seals the reservoir. In one embodiment, the plunger in the lower position further closes the sample outlet so that fluid contained in the test compartment does not re-enter the lower chamber.

  A “sample collection well” is where a fluid sample is collected in preparation for analysis. In one embodiment, the shape of the sample collection well is generally cylindrical, but in other embodiments it can take any shape that matches its function. The sample collection well can have an upper chamber and a lower chamber. In one embodiment, the upper chamber is the area above the pressing plate and the lower chamber is the area below the pressing plate. A “squeeze plate” refers to a surface that can compress or squeeze a sample applicator filled with a fluid sample to squeeze the sample from the applicator. The squeezing plate can have openings or holes so that a squeezed fluid sample can be passed through to the sample collection well. The squeeze plate can be placed in the sample collection well, but it can also be placed elsewhere where the squeezed sample can flow into the collection well. In one embodiment, the squeeze plate is located in the sample collection well, divides the upper and lower chambers, and one or more holes through which fluid samples can flow from the upper chamber to the lower chamber Or it has an opening. When the sample applicator is pressed against the pressing plate, the sample flows through the opening of the pressing plate and into the lower chamber. The term “plunger” refers to a part of a device that moves through a portion of the device to bring two parts into contact and perform a function in the operation of the device. In one embodiment, the plunger is similar to a piston and moves in a circular or cylindrical portion of the device. In one embodiment, the plunger moves through the sample collection well.

  In one embodiment, the plunger has one or more plunger arms extending upward. In one embodiment, one or more plunger arms extend upward near the squeeze plate inside the sample collection well. In other embodiments, when the cap is installed in the sample collection well, the bottom of the cap interacts with the plunger arm to move the plunger from the upper position to the lower position. The sample reservoir can be located at the bottom of the sample collection well. In one embodiment, the cap and sample well have complementary engaging threads. Further, when the plunger is in the upper position, the test compartment and the lower chamber of the sample collection well are in fluid communication, and when the thread is fully engaged, the plunger is in the lower position and the test compartment And the lower chamber are not in fluid communication. “Fully engaging” the threads refers to rotating the cap into the sample collection well and engaging the complementary threads to the extent that they can be hand tightened. A sample outlet provides fluid communication between the lower chamber and the test compartment.

  A “test element” may be any element that produces a detectable result. In some embodiments, the test element is a test strip. In some embodiments, the test strip has specific binding molecules immobilized on the test strip, and reagents for performing an immunoassay, while in other embodiments, the test strip comprises It has a chemical test, however, it may have the reagents necessary to perform any suitable test that yields a detectable result. In one embodiment, the test element includes a reagent for detecting the presence of an abused drug.

  The sample may be any fluid sample. Examples of fluid samples include oral fluid, saliva, blood, serum, plasma, urine, stool, spinal fluid, vaginal smear, mucus, and tissue. “Saliva” refers to secretions of the salivary glands. “Oral fluid” is any fluid present in the oral cavity. If the analyte to be detected is an abused drug, the subject's saliva will contain a sufficiently high concentration of drug for testing if the subject has recently taken the drug.

  The sample may be any sample for which a test element is available or can be developed. Examples of analytes of interest include drugs (eg, drugs of abuse), hormones, proteins, peptides, nucleic acid molecules, etiological factors, and members of specific binding pairs. A “drug of abuse” (DOA) is a drug taken for non-medical reasons (usually an effect that changes mental state). Such drug abuse can lead to physical and mental disorders, and (for some substances) can lead to addiction, addiction, and even death. Examples of DOA include cocaine, amphetamines (e.g., black beauty, white Bennies, dextroamphetamines, dexedrines (dexnes), beans (beans), methamphetamines (crankamine). Methadone (meth), crystal, speed), barbiturate (Valium® from Nutley, NJ, New Jersey), sedatives (ie sleep aids), Lysergic acid diethylamide (LSD), depressants (sedatives (do ners), tranquilizers (goofballs), barbiturs (barbs), blue devils, yellow jackets, ludes), tricyclic antidepressants (TCAs such as imipramine) , Amitriptyline, and doxepin), phencyclidine (PCP), tetrahydrocannabinol (THC, pot, dope, cannabis (hash), marijuana (weed), and the like), and Anesthetics (eg, morphine, opium, codeine, heroin, oxycodone). That.

  In another aspect, the present invention provides a kit comprising a test device of the present invention and a sample applicator. The sample applicator can have an absorbent member and a handle. The absorbent member may be a sponge, foam, or any material suitable for fluid absorption. In one embodiment, the absorbent member is treated with a solution that facilitates the secretion of saliva in the subject. In addition, the kit can include instructions for using the device. In one embodiment, the instructions are for using the device to detect the presence of an analyte in oral fluid or saliva.

  In another aspect, the present invention provides a method for detecting an analyte suspected of being present in a liquid sample. The method includes adding a liquid sample suspected of containing an analyte to the sample applicator, adding the liquid sample to the inspection device of the present invention by squeezing the sample applicator to the inspection device, and into the sample. Determining whether the specimen exists. In addition, the method can include moving the plunger to a lower position to seal a portion of the fluid sample in the reservoir. In one embodiment, a sample is applied to the sample applicator by placing the sample applicator in the subject's mouth, thereby leaving the sample applicator filled with the subject's saliva. The liquid sample can be added to the test apparatus by pressing or squeezing the sample applicator by pressing the sample applicator against the squeeze plate of the apparatus so that the liquid sample flows into the sample collection well.

  In addition, the method may include lowering the plunger to a lower position by fully engaging the cap and sample collection well threads to seal the sample portion in the reservoir. In other embodiments, the method includes lowering the plunger to a lower position by placing a cap into the sample collection well to seal the sample fraction in the reservoir.

  The present invention includes various other useful embodiments detailed herein. Those aspects of the invention can be realized using the products and compositions described herein. It will be further understood by reference to the disclosure herein that various aspects of the invention can be combined to form a desired embodiment of the invention. In addition, various other aspects and embodiments of the invention are described herein.

  The summary of the invention described above is not intended to limit the invention, and other features and advantages of the invention will be apparent from the following detailed description, and from the claims.

  In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. Yes. It should be understood that other embodiments may be used and structural changes may be made without departing from the scope of the invention.

  One aspect of the invention is an inspection apparatus for inspecting a fluid sample for the presence of an analyte. Further, according to this apparatus, a large amount of sample can be easily stored in the reservoir of the apparatus for later confirmation inspection. If desired, other inspection principles can be used in the verification inspection. In this way, the verification sample is safely protected from contamination. Confirmation samples can be easily isolated during normal assay procedures without having to perform any further steps. In one embodiment, when the cap is attached to the device by the user, the use of the cap lowers the seal over the reservoir so that the verification sample is automatically isolated in the reservoir for future testing. .

1 to 9 show an embodiment of the present invention, that is, an inspection apparatus 100 for detecting an analyte suspected of being present in a fluid sample. As shown in FIGS. 1 to 3, the inspection apparatus includes a casing 110 and a sampling well 120 (see FIG. 5). The casing is composed of an upper part 240 and a base part 245. The casing has a port 150 in which the sample collection well is associated with the casing and the inspection compartment (reference number 630 in FIG. 6). The test compartment contains at least one test element 280, such as a test strip. In this embodiment, the upper part of the casing has a window 190 through which the test results on the test strip can be viewed. The sample collection well is located in the port and has an upper chamber 130, a squeeze plate 320, a lower chamber 330, and a sample outlet 270, where the sample outlet 270 is between the sample collection well and the test compartment. Has brought fluid communication. In one embodiment, fluid communication is provided when the plunger is in the upper position, and fluid communication does not occur when the plunger is in the lower position.

  The pressing plate has one or more openings 420 through which fluid can flow and pass. In addition, the squeeze plate may have an opening sized and shaped such that fluid can be removed from the lower chamber by a pipette, syringe, or other convenient means. In this embodiment, a squeeze plate is located in the sample collection well to separate the upper chamber from the lower chamber. However, in other embodiments, the placement of the squeeze plate can vary.

  The reservoir 250 is located in the lower chamber or below the lower chamber, and can store a fluid sample for confirmation testing. In some embodiments, the reservoir is vertically aligned with the port. In one embodiment, the reservoir is a depression (shown) in the lower surface of the sample collection well. In other embodiments, the reservoir may be a chamber or other storage area that receives a fluid sample from a sample collection well. In the illustrated embodiment, the reservoir is located at the bottom of the sample collection well, and in other embodiments it can be located at the lower end of the sample collection well, or even elsewhere.

  In addition, the sample collection well has a plunger 220 having both an upper position and a lower position within the sample collection chamber (see FIGS. 6-9). In one embodiment, the plunger has a seal 230 attached to the lower end. When the plunger is in the upper position, the lower chamber and the test compartment are in fluid communication with each other through the sample outlet and fluid flows freely through the sample outlet from the lower chamber of the sample collection well to the test compartment. (See FIGS. 7 and 8). When the plunger is in the down position, a seal is placed over the reservoir (or opening to the reservoir) to have a contact point 910 with the reservoir and seal the lower chamber from the reservoir. Furthermore, when the plunger is in the lower position, the lower chamber is also sealed from the test compartment by closing the sample outlet (FIG. 9). When the lower chamber is sealed from the test compartment, the lower chamber and the test compartment are no longer in fluid communication with each other and no fluid flows from the lower chamber to the test compartment. In other embodiments, the seal may exist as a separate part driven by the movement of the plunger. For example, a seal may be present at the bottom of the sample collection cup. In one embodiment, the seal may be an O-ring located around the opening to the reservoir and closed by a plunger that descends into the opening. In other embodiments, the seal may be a separate part located above the reservoir opening and pushed by the plunger as it moves to the lower position to form a seal around the reservoir. Good.

  In another embodiment, the inspection device further includes a cap 210 for the sample collection well. In one embodiment, the cap and sample collection well have complementary engaging threads. In the illustrated embodiment, the cap is configured to interact with the plunger to move the plunger from the upper position to the lower position when the cap is installed in the sample collection well. . This interaction may be a physical contact between the parts, where contact with the cap transfers force to the plunger, causing movement of the plunger to a lower position. In one embodiment, the bottom of the cap interacts with the plunger to apply force as the cap is screwed into the sample collection well. When the cap is screwed into the sample collection well, the threads are fully engaged and the plunger is moved to the lower position so that the test compartment and the lower chamber are no longer in fluid communication. Furthermore, when the sample outlet is open, fluid communication between the lower chamber and the test compartment is provided by the sample outlet. In some embodiments, threaded caps are used, but other types of caps can be used. For example, a cap may snap into a sample collection well and depress the plunger. Alternatively, the cap may be fitted into the sample collection well in a cork manner, i.e. pushed into the sample collection well, i.e. held in the well by the expansion force of the cap. Any format that serves the purpose of applying force to the plunger while sealing the opening of the sample collection well is suitable.

  In a further embodiment, the plunger has one or more plunger arms 140 extending upward from the direction of the base of the plunger. Further, as shown in FIG. 4, the plunger arm may extend near the squeeze plate or through the squeeze plate and up the inside of the sample collection well. In the illustrated embodiment, a slot 410 is provided in the squeeze plate to accommodate the plunger arm. When the cap is attached to the sample collection well, a portion of the cap (eg, the bottom of the cap) interacts with the plunger arm to move the plunger from the upper position to the lower position. As already explained, when the cap is screwed into the device, the reservoir is sealed and the sample outlet is closed so that the lower chamber and the test compartment are no longer in fluid communication.

Sample Applicator A sample applicator can be supplied to the apparatus of the present invention. In general, the sample applicator is composed of an absorbent member 160 and a handle 180. The absorbent member can be made of a medical quality sponge or foam material commonly used in the art. However, many other materials are available for use as an absorbent member, such as cotton or paper or any material having a suitable absorbent capacity. The handle is generally a rigid body to facilitate operation of the absorbent member. The handle can be made of any material commonly used in the art, such as plastic, wood, metal, or cardboard. In one embodiment, the handle has a rim 170 to which an absorbent member is attached.

  In some embodiments of the present invention, the upper chamber of the sample application well can have vertical ribs 430 (FIG. 4). The applicator can be configured such that when the applicator is fully pressed against the squeeze plate and then twisted to fit under the rib, the rim of the applicator is locked under the rib. it can. Thereby, since the sample contained in the absorption member of an applicator is squeezed as much as possible, sufficient compression of the absorption member of an applicator can be ensured.

Test Strips A variety of test components can be incorporated into the present invention, and a wide variety of test components are known in the art. The discussion here presents only a brief overview of some embodiments. One type of test component is a test strip. Specimen test strips are test components provided in a variety of formats, such as immunoassays or chemical tests, to detect the analyte of interest in a sample, such as drugs of abuse or metabolites that indicate a health condition It is. The test component or test strip can be provided in the form of a non-competitive assay or a competitive assay. In some formats, the test strip has an absorbent material having a sample application area, a reagent area, and a test result area. Sample is added to the sample application area and flows to the reagent area by capillary action. In the reagent area, the sample dissolves and mixes in the reagents necessary for detection of the analyte (if present in the sample). The sample carrying the reagent now flows further into the examination result area. Additional reagents, such as specific binding molecules for the analyte, are immobilized in the test result area. These reagents react and bind to the analyte (if present) or one of the first reagents from the reagent region.

  Typically, in a non-competitive format, a signal is generated when the sample contains an analyte, and no signal is generated when no analyte is present. In a competitive format, a signal is generated when no sample is present, and no signal is generated when a sample is present. Of course, how the results should be interpreted depends on the design of the assay, and those skilled in the art will be familiar with test strip design.

  If the test element is a test strip, it can be made of absorbent and non-absorbable materials. The test strip may include more than one material, which can then be in fluid communication. For example, one material of the test strip, such as filter paper overlaid on nitrocellulose, may be overlaid on the other material of the test strip. Alternatively or additionally, the test strip may comprise a region containing one or more materials followed by a region containing one or more different materials. In this case, the regions are in fluid communication and may or may not partially overlap. To increase handling strength, one or more materials of the test strip may be bonded to a solid surface such as a support or plastic support sheet.

  In embodiments in which the analyte is detected by the signal generation system, such as by one or more enzymes that specifically react with the analyte, one or more components of the signal generation system may be associated with a particular binding member as described above. It can be bound to the analyte detection region of the test strip material in a similar manner as it is bound to the test strip material. Alternatively, or in addition, one or more components of the signal generation system may be included in the sample application area, reagent area, or analyte detection area of the test strip, or included in the entire test strip. The material may be impregnated. This can be accomplished by applying a solution of such a component to the surface or by immersing one or more test strip materials in the solution of such a component. Following one or more applications or one or more dippings, the test strip material is dried. Alternatively, or in addition to this, the components of the signal generation system included in the sample application area, reagent area, or analyte detection area of the test strip, or included throughout the test strip, have been described for labeled reagents. As such, it may be applied to the surface of one or more test strip materials of the test strip.

  The areas are configured in a number of formats, for example, a sample application area, one or more reagent areas, one or more test result determination areas, one or more management areas, one or more tampering areas, and a fluid absorption area. be able to. When the examination result determination area includes a management area, the management area preferably follows the sample detection area of the examination result determination area. All of these regions, or a combination thereof, can be provided on a single test strip of a single material. Alternatively, the regions are made of different materials and connected together in fluid communication. For example, the various regions may be in direct fluid communication or indirect fluid communication. In this case, the various regions can be joined end to end to be in fluid communication, can be superimposed to be in fluid communication, or filter paper, glass fiber, or nitro It can be in fluid communication by other members, such as a connection material that is preferably absorbent, such as cellulose. When using a connecting material, the connecting material is either end-to-end connected region or a material comprising such a region, and the end-to-end connected region or the region thereof is not in fluid communication. Such as, but not limited to, an area that is in fluid communication with a material that includes or is overlapping (such as, but not limited to, from top to bottom) or such The material containing the region can be connected.

  When the test strip includes a falsification management area, the falsification management area can be arranged before or after the result determination area. If there is a management area in the result determination area of such a test strip, the falsification management area is preferably located in front of the management area, but this is not necessarily so. In embodiments of the invention in which the test strip is a managed test strip for tampering specimen and / or management decisions, the tamper management area can be placed before or after the management area, but preferably the tamper management area. Is in front of the management area. The tamper region provides a signal when the mixture to be examined is present in the sample to determine whether an attempt to nullify the purpose of the assay has been made by the subject.

  Any specimen can be examined using the present invention and a suitable test element. In particular, the present invention can be used to detect drugs of abuse in saliva or oral fluid. Other examples of specimens to be tested include, but are not limited to, creatinine, bilirubin, nitrite, protein (non-specific), hormones (eg, human chorionic gonadotropin, luteinizing hormone, follicle stimulating hormone) Etc.), blood, white blood cells, sugars, heavy metals or toxins, bacterial components (eg E. coli O157: H7, Staphylococcus aureus, Salmonella, Welsh, Campylobacter, Listeria monocytogenes, Vibrio parahaemolyticus, or Bacillus cereus) Specific proteins or sugars) and material properties of urine samples such as pH and specific gravity. Any other clinical urine chemistry specimen that can be adapted to the lateral flow test format can also be incorporated into the device of the present invention.

Sample Types Any type of sample, including fluids of biological origin (eg, body fluids and clinical samples) can be examined with the device of the present invention. Liquid samples can be derived from solid or semi-solid samples, including stool, biological tissue, or food samples. Such solid or semi-solid samples can be mixed, cut, soaked, cultured, lysed, or the solid sample in a suitable liquid (eg, water, phosphate buffered saline, or other buffer) It can be converted to a liquid sample by any suitable method, such as enzymatic digestion. “Biological samples” include, for example, urine, saliva, blood and blood components from humans or animals, cerebrospinal fluid, vaginal smears, semen, feces, sweat, exudate, tissues, organs, tumors, tissues and Examples include samples derived from living animals, plants, and foods, such as organ cultures, cell cultures, or conditioned media therefrom. A preferred biological sample is urine. Food samples include samples from processed food ingredients or finished products, meat, cheese, wine, milk, and drinking water. Plant samples include those derived from any plant, plant tissue, plant cell culture, and conditioned media therefrom. “Environmental samples” include samples derived from the environment (eg, water samples from lakes or other waters, waste samples, soil samples, ground water, sea water, and spring water). Sewage and related excreta can also be included in the environmental sample.

Method of Use Another aspect of the present invention is a method for detecting an analyte suspected of being present in a liquid sample as described above. One embodiment is shown in FIG. Note the position of the sample applicator in the top and bottom cross-sectional views. In use, an applicator is fitted into the upper chamber of the sample well and placed against the pressing plate. At this point, the plunger is in the upper position with the seal attached to the plunger. Because the fluid entering the lower chamber can flow through the sample outlet and into the test compartment, the lower chamber is in fluid communication with the test compartment.

  In some embodiments of the present invention, a small strip of wicking paper 620 is disposed between the sample application area and the sample outlet of the test strip. This facilitates sample flow from the sample collection well through the sample outlet to the test strip. Any type of absorbent material that supports capillary flow can be used as the core paper. For example, a small strip of glass fiber paper treated with a buffer and surfactant to make it hydrophobic can be used, or polyester fiber that has also been treated to make it more hydrophobic.

  The core paper can be used to adjust the properties of the sample before being incorporated into the test strip. For example (when the presence of a drug is tested), saliva may contain antibodies that cross-react with one of the anti-drug antibodies. Therefore, an antibody (scavenger antibody) that reacts with the saliva antibody to inactivate it can be attached to the core paper. If saliva is very viscous and therefore the sample permeates slowly through the test strip, buffers, surfactants, and proteases are added to the core to denature and degrade the proteins in the saliva to reduce viscosity. Can be included in paper.

  In one embodiment of the present invention, a sample is added to the sample applicator by placing the sample applicator in the subject's mouth and the absorbent member is filled with saliva. The applicator may be placed in a pre-sampled sample beaker or tube until the absorbent member is full. If the sample is pre-collected and stored in a separate container, such as a tube or lidded cup, you can pipette a small amount of sample into the sample well as much as is absorbed by the absorbent member. Good. In some embodiments, about 100 μl to about 250 μl of sample can be pipetted into sample wells. However, the amount of fluid sample added to the sample collection well may be any suitable amount, such as, for example, about 250 μl to 500 μl, or about 500 μl to 750 μl, or about 1 ml. “About” means plus or minus 10%.

  FIG. 7 shows the liquid sample added to the test device by pressing the sample applicator against the squeeze plate of the device and squeezing the sample applicator so that the liquid sample flows into the bottom chamber of the sample collection well. ing. Note that in this embodiment, the applicator is depressed and twisted so that the rim of the applicator is locked below the flange 430. A squeezed sample 710 passes through the orifice of the squeeze plate and is collected in the lower chamber. The plunger and seal are still in the upper position. The core paper contacts the sample that has been squeezed and passed through the sample outlet, the sample is allowed to escape to the test strip by the core paper, and the assay is started.

  In a further embodiment, the cap and sampling well have complementary engaging threads (see FIGS. 8 and 9). These embodiments fully engage the cap and sampling well threads, thereby lowering the plunger to the lower position and the reservoir (in this embodiment, a recess located at the bottom of the lower chamber). Sealing the sample fraction within. In other embodiments, the method places a cap over the sample collection well (eg, by snapping or pushing) and lowers the plunger to a lower position to seal the sample fraction in the well. Including stages. FIG. 8 shows the start of the placement of the cap on the inspection device. The sample applicator has been removed and discarded. The plunger and seal are still in the upper position, but the top of the arm on the plunger is in contact with the bottom surface of the cap. In addition, the core paper and test compartment are still in fluid communication with the lower chamber.

  The cap is then screwed into the collection well and the threads are fully engaged. As shown in FIG. 9, the cap pushes the arm of the plunger and pushes the plunger and the seal attached to the plunger to the lower position. Note that the seal is in contact with the indentation (see point 910). When this occurs, the sample remaining in the lower chamber is sealed from the examination compartment. Furthermore, the examination compartment is no longer in fluid communication with the rest of the device, in particular with the lower chamber.

Inspection Kit The inspection kit of the present invention can be packed in various formats according to the needs of customers. For example, an organization that performs a number of pre-employment drug tests may prefer a set of instructions and 20 sets of vacuum-packed devices and applicators. On the other hand, another user may prefer a boxing kit that includes only one device, one sampler, and one set of instructions. Any suitable packaging material can be used. The test kit can be packaged in a box or wrapped with a protective material such as cellophane. Furthermore, the test kit can comprise a test device (and applicator) provided in the same or separate sealed sachet, such sachet further provided in a box or other packaging. May or may not be provided.

Example 1 Pre-employment Drug Testing The device of the present invention can be used in a variety of situations, such as in pre-employment drug testing. The person to be tested provides a sample of oral fluid by placing the sample applicator in his mouth and keeping it in the mouth for about 5 minutes. In an embodiment for pre-employment drug testing, the device contains test strips for several common abuse drugs, including cocaine, methamphetamine, phencyclidine, THC, morphine, and amphetamine in this embodiment. is doing. These test strips use a competitive immunoassay format in which the labeled specific binding molecules (in this embodiment, antibodies) for each drug being tested are labeled in the test strip label region ( Or it exists in the reagent region). The inspection line includes the antigen to be inspected. When analyte is present in the sample, the specific binding molecule labeled in the label region binds to the analyte, thus preventing the labeled antibody from binding to the test line. Therefore, when the specimen exists, no signal is generated on the inspection line. In contrast, if no antigen is present in saliva, the labeled antibody binds to the test line and results in a signal on the test line.

  After receiving the filled or fully moistened sample applicator, the laboratory technician inserts it into the sample collection well of the device, pushes the applicator down into the squeeze plate and then twists it to rim the applicator. Is locked below a pair of flanges (provided in this embodiment). As a result, saliva is squeezed from the absorbent foam of the sample applicator, passes through the hole in the pressing plate, and flows into the lower chamber of the sample collection well. Since the plunger is in the first position, the sample further flows through the sample outlet into the test compartment. As the sample flows into the lower chamber of the sample collection well, it contacts the core paper extending into the lower chamber, exits the sample outlet and flows to the test strip, and the assay is initiated. When all of the sample has been taken, the applicator is discarded and the cap is screwed into the sample collection well. When the cap is screwed into the device, the force applied by the cap pushes the plunger to the down position. As the plunger moves to the lower position, the seal is lowered around the reservoir and the fluid sample fraction is isolated in the reservoir. When the plunger is lowered, the sample outlet is also closed and any further sample flow to the examination compartment is stopped. After about 3 to 5 minutes, a control sign is provided indicating that the assay is complete. The test line for each drug to be tested provides a signal indicating that no abused drug is present in the saliva sample (this test is a competitive format). If a positive result is obtained, the device can be sent to a confirming laboratory so that the portion of the sample contained in the reservoir can be examined to confirm the result.

  The invention described herein by way of example may be practiced without any one or more elements or one or more limitations not specifically disclosed herein. . The terms and expressions used are used as descriptive terms and are not used as limiting terms, and the use of such terms and expressions may include any equivalent of the features shown and described or It is not intended to exclude a portion thereof, but it will be understood that various modifications can be made within the scope of the invention as set forth in the claims. Thus, although the present invention has been specifically disclosed with various embodiments and optional features, those skilled in the art can make changes and modifications to the concepts disclosed herein. It should be understood that variations are considered to be included within the scope of the invention as defined by the claims.

  The content of papers, patents and patent applications, as well as any other literature, and electronically available information mentioned or cited herein, is as if each such publication was incorporated by reference. To the extent that they are specifically and individually indicated, the entirety of which is incorporated herein by reference. Applicants reserve the right to physically incorporate any and all subject matter and information from any such article, patent, patent application, or other document into the present application.

It is a perspective view of one embodiment of the present invention. FIG. 2 is an exploded view of the apparatus of FIG. FIG. 2 is another exploded view of the apparatus of FIG. All six sides of the device of FIG. 1 are shown. A top view, a side view, a cross-sectional view, and a perspective view of the sample application well 120 are shown. The external view and sectional drawing of the apparatus of FIG. 1 are shown, and the state of the apparatus before use is shown. A downward arrow indicates the expected path of the fluid squeezed out to the lower chamber 330. FIG. 2 shows an external view and a cross-sectional view of the apparatus of FIG. The external view and sectional drawing of the apparatus of FIG. 1 are shown, and the state of the apparatus before sealing the lower chamber 330 is shown. FIG. 2 shows an external view and a cross-sectional view of the apparatus of FIG. 1, showing the state of the apparatus after the cap is attached.

Claims (29)

An inspection device for detecting an analyte suspected of being present in a fluid sample,
A casing with a port for sample collection wells;
An inspection compartment containing at least one inspection element;
A sampling wells located within the port, comprising a sample outlet for providing fluid communication of the lower chamber, and sample collection well and the test compartment, and the sampling wells,
A lower chamber or the lower chamber below the reservoir of the sample collection well, receives a fluid sample from the sample collection well, and stores the fluid sample for confirmation testing, and the reservoir,
A plunger contained within the sample collection well and having an upper position and a lower position;
Plunger are positioned in the lower position, and a seal configured to seal the sample outlet to prevent fluid communication between the reservoir and the examination zone, device.   The apparatus of claim 1, wherein the plunger further comprises one or more plunger arms extending upwardly from the direction of the base. The apparatus of claim 2, wherein the sample collection well further comprises a squeeze plate, and wherein the one or more plunger arms extend upwardly inside the sample collection well near the squeeze plate.   4. The apparatus of claim 3, wherein when the cap is attached to the sample collection well, a portion of the cap interacts with the plunger arm to move the plunger from the upper position to the lower position.   The apparatus of claim 1, wherein the reservoir is a depression located at the base of the sample collection well. The apparatus of claim 1, wherein the inspection apparatus further comprises a cap, and the cap and the sample collection well comprise complementary engaging threads.   When the plunger is in the upper position, the test compartment and the lower chamber are in fluid communication, and when the thread is fully engaged, the plunger is in the lower position and the test compartment and the lower chamber are in fluid communication. 7. The device of claim 6, wherein:   The apparatus of claim 1, wherein the sample outlet provides fluid communication between the lower chamber and the test compartment.   The apparatus of claim 1, wherein the test element is a test strip.   The apparatus of claim 9, wherein the test strip comprises a specific binding molecule immobilized on the test strip.   The apparatus of claim 9, wherein the test strip comprises a chemical test.   The device of claim 1, wherein the sample is selected from the group consisting of oral fluid, saliva, blood, serum, plasma, urine, feces, spinal fluid, vaginal smear, mucus, and tissue.   The apparatus of claim 12, wherein the fluid sample is saliva. 2. The device of claim 1, wherein the analyte of interest is selected from the group consisting of drugs, hormones, proteins, nucleic acid molecules, etiological factors, and members of specific binding pairs. 15. The device of claim 14, wherein the analyte is a drug and the drug is an abused drug. A kit comprising an inspection device for detecting an analyte suspected of being present in a fluid sample, the inspection device comprising:
A casing with a port for sample collection wells;
An inspection compartment containing at least one inspection element;
A sampling wells located within the port, comprising a sample outlet for providing fluid communication of the lower chamber, and sample collection well and the test compartment, and the sampling wells,
A lower chamber or the lower chamber below the reservoir of the sample collection well, receives a fluid sample from the sample collection well, and stores the fluid sample for confirmation testing, and the reservoir,
A plunger contained within the sample collection well and having an upper position and a lower position ;
A seal configured to seal the sample outlet to prevent fluid communication between the reservoir and the test compartment when the plunger is in the lower position;
And a sample applicator, kit.   The kit of claim 16, wherein the sample applicator comprises an absorbent member and a handle.   The kit according to claim 17, wherein the absorbent member is a sponge or a foam.   The kit according to claim 17, wherein the absorbent member is treated with a solution that promotes the secretion of saliva in the subject. 18. The kit of claim 17, further comprising instructions for using the testing device to determine the presence of the analyte in saliva. A method for detecting an analyte suspected of being present in a liquid sample, comprising:
Adding a liquid sample suspected of containing an analyte to the sample applicator;
Adding a liquid sample to the inspection device by squeezing the sample applicator to the inspection device, the inspection device comprising:
A casing with a port for sample collection wells;
An inspection compartment containing at least one inspection element;
A sampling wells located within the port, comprising a sample outlet for providing fluid communication of the lower chamber, and sample collection well and the test compartment, and the sampling wells,
A lower chamber or the lower chamber below the reservoir of the sample collection well, receives a fluid sample from the sample collection well, and stores the fluid sample for confirmation testing, and the reservoir,
Are encompassed sampling the well, the plunger closed the upper and lower positions,
A seal configured to seal the sample outlet to prevent fluid communication between the reservoir and the test compartment when the plunger is in the lower position;
The method further comprises:
Determining whether an analyte is present in the sample. By placing the sample applicator into the mouth of a subject, adding the sample to the sample applicator, the method according to claim 21.   The method of claim 21, wherein the sample applicator is filled with saliva. As the liquid body sample to flow to the lower portion room of sampling wells, against to squeeze plate configured to sample applicator sampling the well by squeezing the sample applicator, applying a liquid sample to the test device 24. The method of claim 23. The method of claim 21, wherein the test device further comprises a cap, and the cap and sample collection well comprise complementary engaging threads.   26. The method of claim 25, further comprising lowering the plunger to a lower position by fully engaging the cap and sample collection well threads to seal the sample fraction in the reservoir.   24. The method of claim 21, further comprising placing a cap into the sample collection well and lowering the plunger to a lower position to seal the sample fraction in the reservoir.   The method of claim 21, wherein the test element is a test strip.   30. The method of claim 28, wherein the test strip comprises a reagent for detecting the presence of an abused drug.

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